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Psychosexual Intervention in Patients With Stage I-III Gynecologic or Breast Cancer

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ClinicalTrials.gov Identifier: NCT01764802
Recruitment Status : Recruiting
First Posted : January 10, 2013
Last Update Posted : April 13, 2017
Sponsor:
Collaborator:
Information provided by (Responsible Party):

January 8, 2013
January 10, 2013
April 13, 2017
October 2010
August 2018   (Final data collection date for primary outcome measure)
  • Sexual behavior/repertoire (kissing, intercourse, etc.) graded using the Sexual Experiences Scale (SES) [ Time Frame: Up to 2 months ]
    Multilevel modeling will be used to model time effects compared to repeated-measures analysis of variance (ANOVA) because it allows not only fitting different patterns of average change (i.e., linear, quadratic), but also estimates individual variability in the rate of change. Both linear and quadratic change models will be tested and an optimal model will be determined. 95% confidence intervals will be obtained.
  • Sexual responsiveness (desire, arousal, orgasm) using the Female Sexual Functioning Index (FSFI) [ Time Frame: Up to 4 weeks ]
    Principal components analysis yields six subscales: desire, arousal, lubrication, orgasm, satisfaction, and pain. Items are rated using the Likert scales. 95% confidence intervals will be obtained.
  • Sexual satisfaction graded using the global evaluation from the Derogatis Sexual Function Inventory (DSFI) [ Time Frame: Up to 2 months ]
    95% confidence intervals will be obtained.
  • Sexual distress graded using the female Sexual Distress Scale (FSDS) [ Time Frame: Up to 4 weeks ]
    The Likert scale will be used. 95% confidence intervals will be obtained.
  • Sexual pain graded using the International Pelvic Pain Society Pelvic Pain Assessment, patient/physician version [ Time Frame: Up to 9 months ]
Same as current
Complete list of historical versions of study NCT01764802 on ClinicalTrials.gov Archive Site
  • Emotional distress graded using the Profile of Mood States (POMS) [ Time Frame: Up to 9 months ]
    The Likert scale will be used. 95% confidence intervals will be obtained.
  • Depressive symptoms graded using the Center for Epidemiologic Studies Depression Scale (CES-D) [ Time Frame: Up to 9 months ]
    The Likert scale will be used. 95% confidence intervals will be obtained.
  • Health-related quality of life graded according to the RAND Medical Outcomes Study, Short-form 12 (SF-12) [ Time Frame: Up to 9 months ]
    The eight primary subscales are summarized into two component scores: the Physical Component Summary (PCS) and the Mental Component Summary (MCS).
  • Cancer-related stress graded according to the Impact of Events Scale-Revised (IES-R) [ Time Frame: Up to 9 months ]
  • Body change stress graded according to the Impact of Treatment Scale (ITS) [ Time Frame: Up to 9 months ]
Same as current
Not Provided
Not Provided
 
Psychosexual Intervention in Patients With Stage I-III Gynecologic or Breast Cancer
Psychosexual Intervention for Gynecologic and Breast Cancer Patients
This randomized phase II trial studies how well psychosexual intervention works in patients with stage I-III gynecologic or breast cancer. Psychosexual intervention may improve sexual and psychosocial function.

PRIMARY OBJECTIVES:

I. Efficacy for reducing the severity of sexual distress, difficulty, and dysfunction in a phase II randomized clinical trial (RCT).

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I (Enhanced standard care): Patients participate in enhanced standard care intervention comprising stress reduction, information delivery regarding gynecologic or breast cancer treatments and sexuality, and provision of a survivorship care plan (SCP) created using OncoLink over 1 hour following baseline assessment and before 6 months.

ARM II (Psychological intervention): Patients participate in individual or group therapy over 1.5 hours weekly for 4 weeks, bi-weekly for 8 weeks, and monthly for 2 months and complete assessment interviews.

After completion of study treatment, patients are followed up at 3, 6, and 9 months.

Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
  • Ovarian Sarcoma
  • Ovarian Stromal Cancer
  • Stage I Uterine Sarcoma
  • Stage I Vaginal Cancer
  • Stage I Vulvar Cancer
  • Stage IA Cervical Cancer
  • Stage IA Endometrial Carcinoma
  • Stage IA Fallopian Tube Cancer
  • Stage IA Ovarian Epithelial Cancer
  • Stage IA Ovarian Germ Cell Tumor
  • Stage IA Primary Peritoneal Cavity Cancer
  • Stage IB Cervical Cancer
  • Stage IB Endometrial Carcinoma
  • Stage IB Fallopian Tube Cancer
  • Stage IB Ovarian Epithelial Cancer
  • Stage IB Ovarian Germ Cell Tumor
  • Stage IB Primary Peritoneal Cavity Cancer
  • Stage IC Fallopian Tube Cancer
  • Stage IC Ovarian Epithelial Cancer
  • Stage IC Ovarian Germ Cell Tumor
  • Stage IC Primary Peritoneal Cavity Cancer
  • Stage II Endometrial Carcinoma
  • Stage II Gestational Trophoblastic Tumor
  • Stage II Uterine Sarcoma
  • Stage II Vaginal Cancer
  • Stage II Vulvar Cancer
  • Stage IIA Cervical Cancer
  • Stage IIA Fallopian Tube Cancer
  • Stage IIA Ovarian Epithelial Cancer
  • Stage IIA Ovarian Germ Cell Tumor
  • Stage IIA Primary Peritoneal Cavity Cancer
  • Stage IIB Cervical Cancer
  • Stage IIB Fallopian Tube Cancer
  • Stage IIB Ovarian Epithelial Cancer
  • Stage IIB Ovarian Germ Cell Tumor
  • Stage IIB Primary Peritoneal Cavity Cancer
  • Stage IIC Fallopian Tube Cancer
  • Stage IIC Ovarian Epithelial Cancer
  • Stage IIC Ovarian Germ Cell Tumor
  • Stage IIC Primary Peritoneal Cavity Cancer
  • Stage III Gestational Trophoblastic Tumor
  • Stage III Uterine Sarcoma
  • Stage III Vaginal Cancer
  • Stage III Vulvar Cancer
  • Stage IIIA Cervical Cancer
  • Stage IIIA Endometrial Carcinoma
  • Stage IIIA Fallopian Tube Cancer
  • Stage IIIA Ovarian Epithelial Cancer
  • Stage IIIA Ovarian Germ Cell Tumor
  • Stage IIIA Primary Peritoneal Cavity Cancer
  • Stage IIIB Cervical Cancer
  • Stage IIIB Endometrial Carcinoma
  • Stage IIIB Fallopian Tube Cancer
  • Stage IIIB Ovarian Epithelial Cancer
  • Stage IIIB Ovarian Germ Cell Tumor
  • Stage IIIB Primary Peritoneal Cavity Cancer
  • Stage IIIC Endometrial Carcinoma
  • Stage IIIC Fallopian Tube Cancer
  • Stage IIIC Ovarian Epithelial Cancer
  • Stage IIIC Ovarian Germ Cell Tumor
  • Stage IIIC Primary Peritoneal Cavity Cancer
  • Breast Cancer
  • Other: behavioral, psychological or informational intervention
    Participate in enhanced standard care
  • Other: behavioral, psychological or informational intervention
    Participate in psychological intervention
  • Active Comparator: Arm I (enhanced standard care)
    Patients participate in enhanced standard care intervention comprising stress reduction, information delivery regarding cancer treatments and sexuality delivered over two sessions.
    Intervention: Other: behavioral, psychological or informational intervention
  • Experimental: Arm II (psychological intervention)
    Patients participate in individual or group therapy over 1.5 hours weekly for 6 weeks, bi-weekly for 8 weeks, and monthly for 2 months and complete assessment interviews.
    Intervention: Other: behavioral, psychological or informational intervention
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
100
Not Provided
August 2018   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Stage I-III gynecologic (any site) or breast cancer
  • Able to speak/read English
  • Able to give informed consent

Exclusion Criteria:

  • Prior non-gynecologic/breast cancer diagnosis
  • Refusal of any cancer treatment(s)
  • Non-ambulatory
  • Concurrent diagnosis of organic brain syndrome, dementia, mental retardation, or significant sensory deficit
  • Major mental illness (e.g, schizophrenia, major depressive disorder)
  • Current/recent (prior 12 months) pregnancy
  • Residence > 70 miles from research site
Sexes Eligible for Study: Female
21 Years to 80 Years   (Adult, Senior)
No
Contact: Ohio State University Comprehensive Cancer Center 1-800-293-5066 Jamesline@osumc.edu
Contact: Nichole Storey 614-685-8754 nichole.storey@osumc.edu
United States
 
 
NCT01764802
OSU-10077
NCI-2012-01341 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
1R21CA149675-01A1 ( U.S. NIH Grant/Contract )
Yes
Not Provided
Not Provided
Kristen Carpenter, Ohio State University Comprehensive Cancer Center
Ohio State University Comprehensive Cancer Center
National Cancer Institute (NCI)
Principal Investigator: Kristen M. Carpenter, Ph.D Ohio State University Comprehensive Cancer Center
Ohio State University Comprehensive Cancer Center
April 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP